Opinion: On the Gene Patent Debate

Two key patent cases that no doubt will impact the future of personalized medicine are pending review by the US Supreme Court. What will the Court decide?

By Courtenay C. Brinckerhoff | March 7, 2012

FLICKR, BRIAN TURNER

The debate over the patenting of technologies related to diagnostic and personalized medicine continues to swell with no resolution in sight. The Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. last December, but has not yet issued a decision. Just last month, the US Patent and Trademark Office held public hearings to gather information for the “study on genetic testing” that it will use to prepare a report for Congress on this issue. And, the Supreme Court is deciding whether to review the Federal Circuit decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the BRCAI/gene patenting case), although current speculation is that the Court may defer any action on this case until it issues its decision in Prometheus. While each of these proceedings raises different legal issues, they all relate to the ability to obtain or enforce patent rights on genes, tests, and methods used in personalized medicine.

Personalized medicine is the new frontier of healthcare. It offers the promise of treatments that are tailored to a patient’s individual situation, including the patient’s genetic makeup, the specific variation of the disease the patient suffers from, and the patient’s specific response to a given course of treatment. With personalized medicine, a patient can be given the most effective treatment, improving prognosis and saving considerable time and money on ineffective treatments. As noted on the US Food and Drug Administration’s Pharmacogentics webpage, “[p]harmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.”

The question being debated is whether these advances are most likely to flourish within the patent system or outside of it. Do patents promote investment in personalized medicine or stifle innovation by suppressing competition? Do patients benefit from patented therapies, or do they suffer without treatments because they are too expensive? The Founding Fathers established the patent system in the US Constitution as an incentive to “promote the Progress of Science and useful Arts,” but should a different paradigm apply to medical inventions?

Companies working in this field cite the high cost of developing and validating personalized medicine therapies, and emphasize the need to obtain a return on their successful investments. Without the promise of some period of market exclusivity during which they can profit from their years of research, companies will not have any incentive to work in this field—or any resources to do so.

On the other side of the debate, some doctors’ organizations and patient groups believe that the patent system is bad for the healthcare system. They say that it drives up costs and may prevent patients from obtaining a second opinion, because the patent owner can prevent others from administering patented tests. Many believe that research would continue—at universities and institutions like the National Institutes of Health—and that more people would benefit because the advances would be available on a more widespread basis.

At its heart, this debate may be more of a public policy question than a legal one. People deciding this issue must keep in mind that most university research is funded by government grants and that NIH is a federal agency. We may want taxpayer money to support this kind of research, but it raises the same specter of big government and taxpayer burden as health care reform. Is a country that may not be ready to provide universal access to proven therapies willing to invest substantial amounts in research programs that may take years to yield any benefits?

Turning back to the law, the US Court of Appeals for the Federal Circuit has refused to draw a line that categorically prohibits patents on personalized medicine. In Prometheus, the court found that methods of optimizing the dose of a specific type of drug was patent-eligible subject matter, not an improper attempt to patent a natural phenomenon. In Myriad, the court found that isolated DNA associated with an aggressive form of breast cancer could also be patented without violating the prohibition against patents on products of nature because DNA does not naturally occur in an “isolated” form. Although the Supreme Court could reach a different conclusion in either or both cases, its refusal to categorically prohibit business method patents suggests that it may also approach this issue in a similar fashion—cautiously and on a case-by-case basis. That would leave it to Congress to decide if a different approach is needed (such as compulsory licensing as discussed at the Patent Office hearing), or if the current incentives and rewards are striking an adequate balance between private investment and public benefit.

Courtenay C. Brinckerhoff is a partner at Foley & Lardner LLP, vice chair of the firm’s Chemical, Biotechnology & Pharmaceutical Practice, and editor of Foley’s PharmaPatentsBlog.com. The opinions expressed here do not represent those of Foley & Lardner LLP or its clients.

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Publicly funded researchers at publicly funded universities want publicly funded protection (patents) on naturally occurring products so that they can sell it backÂ to the public for private profit? (Thankfully the persons who first "discovered" air, water and fire didn't have patent attorneys.)

Publicly funded researchers at publicly funded universities want publicly funded protection (patents) on naturally occurring products so that they can sellÂ them backÂ to the public for private profit? (Thankfully the persons who first "discovered" air, water and fire didn't have patent attorneys.)

"Publicly funded" researchers do receive highly variable amounts of money from governmental entities for their research. But the picture needs clarification.

1. How much and from where? Â Â Â If it is a professor, the university may pay anywhere between $20,000 (adjunct) and $210,000 fairly senior) to a science professor's salary out of its general fund. There may be supplements (in medicine related research) of up to $50,000 from grants to those professors up to the NIH salary cap. A post-doc may get $28,000 - $65,000 from NIH grant money. A grad student may get $0 - $22,000 yearly from grants, fellowships or department funds.

2. What is the value of that work? Â Â MDs in the university system make anywhere from $60,000 (interns) to $1.5 million (certain specialists).Â They go to school for 6 -8 years for that on top of undergraduate degree. Â Â PhDs in the university system make anywhere from $0 to $210,000 or so. They go to school for 6-12 years on top of undergrad degree. Then they spend 3-15 years as a post-doc making $28,000 - $65,000. Most never make very much money.

3. Who teaches the MDs? Mostly, it is PhDs and some MDs.

4. Who comes up with new treatments that MDs prescribe?Â Mostly, that is PhDs.

Master plumbers make $100,000 - $250,000. Most PhDs in life sciences never see that kind of money.

And yet - people want to take away the one possible ticket to making a career in life sciences rewarding. Take all the patent rights because "Taxpayers paid your salary!"

By that logic, taxpayers own everything transported in trucks because taxpayers paid for the roads. Taxpayers paid for the airports. Taxpayers paid for building a whole lot of hospitals too.

Scientists work their behinds off to bring the advances that happen. It is not easy.

Publicly funded researchers at publicly funded universities want publicly funded protection (patents) on naturally occurring products so that they can sell it backÂ to the public for private profit? (Thankfully the persons who first "discovered" air, water and fire didn't have patent attorneys.)

Publicly funded researchers at publicly funded universities want publicly funded protection (patents) on naturally occurring products so that they can sellÂ them backÂ to the public for private profit? (Thankfully the persons who first "discovered" air, water and fire didn't have patent attorneys.)

"Publicly funded" researchers do receive highly variable amounts of money from governmental entities for their research. But the picture needs clarification.

1. How much and from where? Â Â Â If it is a professor, the university may pay anywhere between $20,000 (adjunct) and $210,000 fairly senior) to a science professor's salary out of its general fund. There may be supplements (in medicine related research) of up to $50,000 from grants to those professors up to the NIH salary cap. A post-doc may get $28,000 - $65,000 from NIH grant money. A grad student may get $0 - $22,000 yearly from grants, fellowships or department funds.

2. What is the value of that work? Â Â MDs in the university system make anywhere from $60,000 (interns) to $1.5 million (certain specialists).Â They go to school for 6 -8 years for that on top of undergraduate degree. Â Â PhDs in the university system make anywhere from $0 to $210,000 or so. They go to school for 6-12 years on top of undergrad degree. Then they spend 3-15 years as a post-doc making $28,000 - $65,000. Most never make very much money.

3. Who teaches the MDs? Mostly, it is PhDs and some MDs.

4. Who comes up with new treatments that MDs prescribe?Â Mostly, that is PhDs.

Master plumbers make $100,000 - $250,000. Most PhDs in life sciences never see that kind of money.

And yet - people want to take away the one possible ticket to making a career in life sciences rewarding. Take all the patent rights because "Taxpayers paid your salary!"

By that logic, taxpayers own everything transported in trucks because taxpayers paid for the roads. Taxpayers paid for the airports. Taxpayers paid for building a whole lot of hospitals too.

Scientists work their behinds off to bring the advances that happen. It is not easy.

Let's not get carried away.Â The analogous situation with respect to transportation is not for "taxpayers to own everything transported in trucks", it is for the public (including commercial enterprises) to have free access to the roads that have been constructed withÂ tax money -- which is exactly the situation that exists.Â Your analogy seems to favor open access to technology.

Let's not get carried away.Â The analogous situation with respect to transportation is not for "taxpayers to own everything transported in trucks", it is for the public (including commercial enterprises) to have free access to the roads that have been constructed withÂ tax money -- which is exactly the situation that exists.Â Your analogy seems to favor open access to technology.

It is not that simple.Â Getting products to market cost money. The private sector requires some form ofÂ protection in order for them to spend money on developing new tests or drugs.Â That being said, I believe that companies with products that have been developed using public money should have some percentage of theÂ profits plowed back into public research funds.

It is not that simple.Â Getting products to market cost money. The private sector requires some form ofÂ protection in order for them to spend money on developing new tests or drugs.Â That being said, I believe that companies with products that have been developed using public money should have some percentage of theÂ profits plowed back into public research funds.

Most people don't dispute the right for scientists to profit from their "discoveries." It's when people, institutions and companies start trying to patent materials that haveÂ existed for millions and billions of years that we start drawing the line.Â Technology is making it relatively fast and inexpensive to isolate genes and otherÂ natural products, whichÂ then are being patented as if it took incredible innovation and knowledge to find them.Â I say, let the people inventing the machinesÂ that are doing the actual discoveries make the profit.

Most people don't dispute the right for scientists to profit from their "discoveries." It's when people, institutions and companies start trying to patent materials that haveÂ existed for millions and billions of years that we start drawing the line.Â Technology is making it relatively fast and inexpensive to isolate genes and otherÂ natural products, whichÂ then are being patented as if it took incredible innovation and knowledge to find them.Â I say, let the people inventing the machinesÂ that are doing the actual discoveries make the profit.